In the event of the rare occurrence of a reset, healthcare professionals and/or caregivers are required to transfer the patient to another ventilator. Since August 2012, of the more than 14,000 ventilators in use, Medtronic has received 12 reports of the reset without an accompanying alarm. Of these 12 reports, 11 patients required ventilator transfer and one (1) incident did not involve a patient. No patient injury or impairment has been reported. The reported incidence of this condition is approximately one (1) reset in every seven million hours of ventilation.

Medtronic has established the root cause of this alarm failure and will provide a software service update to resolve the issue as soon as the correction can be implemented. The service update is expected to be available May 2017.

Ambulance services with these ventilators are advised to read the MedWatch safety alert for more information and recommendations set out in that document.